Gemcitabine

Generic Name
Gemcitabine
Brand Names
Gemzar
Drug Type
Small Molecule
Chemical Formula
C9H11F2N3O4
CAS Number
95058-81-4
Unique Ingredient Identifier
B76N6SBZ8R
Background

Gemcitabine is a nucleoside analog and a chemotherapeutic agent. It was originally investigated for its antiviral effects, but it is now used as an anticancer therapy for various cancers. Gemcitabine is a cytidine analog with two fluorine atoms replacing the hydroxyl on the ribose. As a prodrug, gemcitabine is transformed into its active metabolites that work by replacing the building blocks of nucleic acids during DNA elongation, arresting tumour growth and promoting apoptosis of malignant cells. The structure, metabolism, and mechanism of action of gemcitabine are similar to cytarabine, but gemcitabine has a wider spectrum of antitumour activity.

Gemcitabine is marketed as Gemzar and it is available as intravenous injection. It is approved by the FDA to treat advanced ovarian cancer in combination with carboplatin, metastatic breast cancer in combination with paclitaxel, non-small cell lung cancer in combination with cisplatin, and pancreatic cancer as monotherapy. It is also being investigated in other cancer and tumour types.

Indication

Gemcitabine is a chemotherapeutic agent used as monotherapy or in combination with other anticancer agents.

In combination with carboplatin, it is indicated for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.

Gemcitabine in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.

In combination with cisplatin, gemcitabine is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). Dual therapy with cisplatin is also used to treat patients with Stage IV (locally advanced or metastatic) transitional cell carcinoma (TCC) of the bladder.

Gemcitabine is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine is indicated for patients previously treated with fluorouracil.

Associated Conditions
Advanced Ovarian Cancer, Bladder Transitional Cell Carcinoma Stage IV, Carcinoma of the Head and Neck, Cervical Cancer, Cutaneous T-Cell Lymphoma (CTCL), Hodgkins Disease (HD), Mesothelioma, Metastatic Breast Cancer, Pancreatic Adenocarcinoma Locally Advanced, Small Cell Lung Cancer (SCLC), Stage IIIA Non Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer (NSCLC), Stage 4 Pancreatic adenocarcinoma
Associated Therapies
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GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma

First Posted Date
2021-06-08
Last Posted Date
2021-06-08
Lead Sponsor
Beijing Tongren Hospital
Target Recruit Count
15
Registration Number
NCT04917250
Locations
🇨🇳

Beijing Tongren Hospital, Beijing, China

Chemotherapy Combined With Tislelizumab as Bladder Sparing Option for Patients With Muscle Invasive Bladder Cancer

First Posted Date
2021-06-02
Last Posted Date
2021-06-02
Lead Sponsor
Ruijin Hospital
Target Recruit Count
40
Registration Number
NCT04909775
Locations
🇨🇳

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China

A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas

First Posted Date
2021-05-28
Last Posted Date
2021-07-28
Lead Sponsor
Brown University
Registration Number
NCT04906876
Locations
🇺🇸

Lifespan Cancer Insitute, Providence, Rhode Island, United States

🇺🇸

Hasbro Children's Hospital, Providence, Rhode Island, United States

PD-1 Blockade Combined With De-intensification Radical Chemoradiotherapy in Nasopharyngeal Carcinoma

First Posted Date
2021-05-28
Last Posted Date
2024-02-06
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
540
Registration Number
NCT04907370
Locations
🇨🇳

Beijing Cancer Hospital, Beijing, Beijing, China

🇨🇳

Panyu central hospital, Guangzhou, Guangdong, China

🇨🇳

Cancer Hospital of Guizhou Medical University, Guiyang, Guizhou, China

and more 9 locations

Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer

First Posted Date
2021-05-26
Last Posted Date
2023-09-01
Lead Sponsor
Changhai Hospital
Target Recruit Count
140
Registration Number
NCT04902261
Locations
🇨🇳

Changhai Hospital, Shanghai, China

Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer

First Posted Date
2021-05-20
Last Posted Date
2024-04-25
Lead Sponsor
EBG MedAustron GmbH
Target Recruit Count
10
Registration Number
NCT04894643
Locations
🇦🇹

EBG MedAustron GmbH, Wiener Neustadt, Niederösterreich, Austria

🇦🇹

Department of Surgery, LK Wiener Neustadt, Wiener Neustadt, Austria

An Open-label, Multicentre, Phase II/III RCT of PFLL Versus GP Combined With JS001 as the First-line Therapy for mNPC

First Posted Date
2021-05-18
Last Posted Date
2021-05-18
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
622
Registration Number
NCT04890522
Locations
🇨🇳

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China

Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery

First Posted Date
2021-05-18
Last Posted Date
2024-06-07
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
164
Registration Number
NCT04891289
Locations
🇺🇸

National Heart, Lung, and Blood Institute (NIH) (Data Collection Only), Bethesda, Maryland, United States

🇺🇸

Washington University (Data Collection Only), Saint Louis, Missouri, United States

🇺🇸

Memorial Sloan Kettering Monmouth - Limited Protocol Activities, Middletown, New Jersey, United States

and more 7 locations

Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

First Posted Date
2021-05-14
Last Posted Date
2024-03-22
Lead Sponsor
G1 Therapeutics, Inc.
Target Recruit Count
92
Registration Number
NCT04887831
Locations
🇺🇸

Tennessee Oncology, PLLC, Nashville, Tennessee, United States

🇺🇸

Beacon Cancer Center PLLC, Coeur d'Alene, Idaho, United States

🇫🇷

Institut Bergonié - Oncologie Médicale et Pédiatrique, Bordeaux cedex, Gironde, France

and more 31 locations
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